Aortic valve no exchange catheter and methods of using the same

ABSTRACT

A medical device used to percutaneously gain access to a targeted site within a living body, for example the left ventricle of the heart. The device is comprised of an inner tubular member, outer tubular member, and an adjustable control handle. The control handle can precisely control the relative position of the inner tubular member relative to the outer member by providing feedback to the operator. This feedback provided by the control handle allows the operator to precisely maneuver the catheter within a body and change the shape of the catheter system without taking his/her eyes off the task that he/she is performing. The control handle is designed to precisely change the catheter system from one tip shape to another tip shape and back. Described herein are methods to use such devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/692,222, filed on Jun. 29, 2018. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The present technology relates to the field of devices used to gainvascular access to regions within a living body.

INTRODUCTION

While there are different methods to gain access to internal organs inthe body to perform a medical procedure, less invasive approaches usingcatheters and guide wires delivered through the body's vascular systemhave become widespread. Minimally invasive procedures offer improvedpatient outcomes, often with fewer complications and shorter recoveryperiods. Consequently, increasingly complex interventional procedureshave been developed to treat various diseases.

In treating heart disease, for example, the use of guide wires andcatheters has a long-established history. Initially, percutaneouscoronary interventions were often directed at diagnosing and treatingblocked vessels within the heart. More recently, technologies to treatstructural heart disorders have been developed and are now part of aninterventionalist's armamentarium. Interventional structural hearttechnologies are comparatively complicated devices requiring advancedtechniques to perform the procedure. For example, in transcatheteraortic valve replacement (TAVR) procedures (also known as percutaneousaortic valve replacement (PAVR) and as transcatheter aortic valveimplantation (TAVI)), a prosthetic valve mounted on a stent is deliveredvia a catheter, over a guide wire, for placement over a patient's nativevalve apparatus.

The TAVR procedure is indicated for patients with severe aortic stenosiswho may be intermediate or high risk for valve replacement surgery. Thenumber of TAVR procedures has grown rapidly, year over year, as patientshave chosen this minimally invasive approach over more traditional openchest, arrested heart procedures requiring a bypass pump. In order toperform a TAVR procedure, the interventionalist must first access theleft ventricle.

Tools to gain access to the left ventricle exist, however, they are notideal. There are numerous steps needed in a TAVR procedure prior todelivering the replacement valve. Developing improved technologies tocombine needed steps can reduce procedural risks associated withmultiple device exchanges. These risks include perforation of the heartor vessels and introduction of emboli resulting in stroke. There areother potential complications. The advanced techniques and the highlevel of concentration required to successfully perform a TAVR procedurehighlights an unmet need to reduce device exchanges as much as possibleto shorten and simplify the procedure in order improve patient outcomes.

In improving intravascular procedures, U.S. Pat. No. 3,503,385 toStevens discloses a vascular diagnostic catheter with an embeddedcontrol wire, spanning from a catheter tip to a proximal (near) handle.A control mechanism attached to the handle manipulates the distal (far)tip of the catheter to form different curves. While this solutionenables changing the shape of the distal end of a catheter, it is acostly solution that reduces space efficiency because of the need tohave pull wires and the required lumens in a catheter shaft to house thepull wires.

U.S. Pat. No. 3,680,562 to Wittes et al. describes a catheter with aninwardly curved tip, like a pigtail, with a series of ports alignedlongitudinally. A hollow piercing member is inserted to straighten thecurved tip to facilitate delivery. There are other devices thatsimilarly change shape using a stiff insertable member into thecatheter. This device and others, which utilize a stiffening insert tochange the shape of the distal end of the catheter, add steps to theprocedure. The stiffening element must be inserted and withdrawn toachieve a shape change. In a complex procedure performed in a settingwith many distractions, there is a need for the operator to be able tomanipulate the catheter distal tip from an initial configuration to afinal configuration quickly and easily, without taking undue attentionand effort.

Pigtail shaped diagnostic catheters have long been used in intravascularmedical procedures. They can be used to infuse imaging agents or drainfluid from organs. In addition, the pigtail configuration can be used tosheath a guide wire, offering protection against injury caused by aguide wire. The curved pigtail shape can have multiple loops whichdeflect the guide wire away from vulnerable tissue. Pigtail catheters,however, are not ideally shaped to traverse the vasculature to reachhard to access areas in the body. Pigtail catheters must often beexchanged with other guiding catheters more suitably shaped to reach aprecise target location in the body. Making catheter exchanges oftenentails the need to exchange guide wires, further complicating theprocedure.

U.S. Pat. No. 4,033,331 to Gus et al. describes the use of a wire toshape the tip of a catheter. The wire, which fills the internal lumen ofthe catheter, then must be extended or retracted to change the shape ofthe distal end. This method of catheter tip shaping can involve manysteps. There is a need for a device which more efficiently reduces thesteps needed to perform a procedure.

U.S. Pat. No. 5,120,323 to Shockey et al. discloses a telescoping guidecatheter system comprised of an inner and outer guide catheter, neitherof which is pre-curved. U.S. Pub. No. 2007/0021732 to Hassett describesan inner guiding introducer and an outer guiding introducer to accessthe left ventricle. Both the inner and outer members are pre-curved.However, both systems lack a means to precisely control retraction andextension of the inner member relative to the outer member.

U.S. Pat. No. 4,960,134 to Webster describes a catheter with asymmetrical cylindrical control handle and a flexible catheter tip. Thecontrol handle comprises a housing having a piston chamber. A piston ismounted in the piston chamber and can move lengthwise. The proximal endof the catheter body is fixedly attached to the distal end of thepiston. A pull wire is attached to the housing and extends through tothe catheter tip. Lengthwise movement of the piston relative to thehousing results in deflection of the catheter tip. While a controlmechanism enables precise tip deflection, the use of pull wires througha catheter using a dedicated lumen precludes a space efficient and costeffective solution.

U.S. Pat. No. 5,666,970 to Smith describes a control mechanism formanipulating the shape of the catheter and providing a rotationallocking mechanism. This solution describes multiple moving elements,including a biasing member to control catheter movement. This complexsolution requires a large housing, which makes it impractical tominiaturize and expensive to manufacture.

In U.S. Pub. No. 2015/0119853 to Gainor et al. describes a convertibleshape catheter and method of use that includes the use of two cathetersdesigned to work in tandem, one inside the other, to achieve any numberof catheter distal tip shapes to advance through the anatomy and providefor a pigtail configuration. This unlimited range of adjustments becomesa hindrance in a procedure on a frail patient, where longer proceduresare associated with serious complications such as renal failure due tothe excessive use of imaging contrast and patient dehydration. For thisdesign, catheter manipulation to change from an initial to a finalorientation requires fluoroscopic visual guidance, with contrast mediainjections. This task may require a degree of operator concentration andextended manipulation that obviates any purported advantages.

The utilization of these prior art devices is highly limited. Theirutility is compromised by size, complexity, difficulty of use, and cost.Consequently, there remains a need for a means to access a preciselocation within the body and provide an easy, controlled, and fastcatheter shape change, in a cost and space efficient manner.

SUMMARY

The present technology relates to ways of using a catheter device toaccess a desired location within a body and effect a change to a distaltip shape of the catheter device, where the ability to change the distaltip shape can provide a shape optimal for insertion/withdrawal of thecatheter device and a shape optimal for an intervention at the desiredlocation.

Methods of using a concentric two-tube catheter device including aninner tubular member and an outer tubular member can include thefollowing aspects. One of the inner tubular member and the outer tubularmember is slidably disposed relative to the other one of the innertubular member and the outer tubular member to expose a distal end ofthe inner tubular member from a distal end of the outer tubular member.The distal end of the outer tubular member can provide a first shape andthe distal end of the inner tubular member can provide a second shapeupon exposure thereof. The first shape and the second shape can bedifferent.

The first shape and the second shape can vary in certain ways. The firstshape can have less curvature than the second shape. The first shape canhave a shorter curved length than the second shape. The first shape caninclude various standardized catheter tip shapes, including variousAmplatz shapes and various Judkins shapes. Certain embodiments includewhere the second shape has a pigtail shape. The second shape can includewhere the distal end of the inner tubular member curves at least about270 degrees from a remainder of the inner tubular member. Of the variousparing options of the first shape and the second shape, a particularembodiment includes where the first shape has a hook shape and thesecond shape has a pigtail shape.

Various aspects of the inner tubular member and the outer tubular membercan include the following. The outer tubular member can have a bendingstiffness greater than a bending stiffness of the inner tubular memberresulting in the second shape of the distal end of the inner tubularmember conforming to the first shape of the distal end of the outertubular member when the distal end of the inner tubular member iscovered by the distal end of the outer tubular member. The inner tubularmember can be slidably disposed to extend from the outer tubular memberto expose the distal end of the inner tubular member from the distal endof the outer tubular member. Alternatively, the outer tubular member canbe slidably disposed to retract from the outer tubular member to exposethe distal end of the inner tubular member from the distal end of theouter tubular member. Slidably disposing one of the inner tubular memberand the outer tubular member relative to the other one of the innertubular member and the outer tubular member to expose the distal end ofthe inner tubular member from the distal end of the outer tubular membercan include slidably disposing a control ring upon a handle body of thecatheter device in a proximal to distal direction on the handle body toextend the inner tubular member relative to the outer tubular member andexpose the distal end of the inner tubular member. Alternatively,slidably disposing one of the inner tubular member and the outer tubularmember relative to the other one of the inner tubular member and theouter tubular member to expose the distal end of the inner tubularmember from the distal end of the outer tubular member includes slidablydisposing a control ring upon a handle body of the catheter device in adistal to proximal direction on the handle body to retract the outertubular member relative to the inner tubular member and expose thedistal end of the inner tubular member. It is also possible to lock theinner tubular member relative to the outer tubular member.

Other aspects of methods of using the concentric two-tube catheterdevice can include the following. Prior to slidably disposing one of theinner tubular member and the outer tubular member relative to the otherone of the inner tubular member and the outer tubular member to expose adistal end of the inner tubular member from a distal end of the outertubular member, the method can include extending a guide wire throughthe distal end of the inner tubular member. Methods can also includemonitoring a pressure at the distal end of the inner tubular memberand/or monitoring a pressure at the distal end of the outer tubularmember. It is also possible to provide a fluid at the distal end of theinner tubular member, withdraw a fluid at the distal end of the innertubular member, provide a fluid at the distal end of the outer tubularmember, and/or withdraw a fluid at the distal end of the outer tubularmember. Such methods can further include inflating a balloon at thedistal end of the inner tubular member and/or inflating a balloon at thedistal end of the outer tubular member. After slidably disposing one ofthe inner tubular member and the outer tubular member relative to theother one of the inner tubular member and the outer tubular member toexpose a distal end of the inner tubular member from a distal end of theouter tubular member, the method can further comprise delivering andinflating a balloon using the catheter device, delivering a stent usingthe catheter device, and/or delivering a prosthetic valve using thecatheter device.

Certain embodiments include methods of treating a heart of a patientusing a concentric two-tube catheter device including an inner tubularmember and an outer tubular member, where such methods include thefollowing steps. The catheter device is advanced through an artery tothe heart of the patient. A guide wire is extended through a distal endof the inner tubular member across an aortic valve of the heart of thepatient. The catheter device is advanced into a ventricle of the heartof the heart of the patient. The outer tubular member is retractedrelative to the inner tubular member to expose a distal end of the innertubular member from a distal end of the outer tubular member, the distalend of the outer tubular member providing a first shape, the distal endof the inner tubular member providing a second shape upon exposurethereof, where the first shape and the second shape are different. Suchmethods can further include one or more of monitoring a pressure at thedistal end of the inner tubular member, monitoring a pressure at thedistal end of the outer tubular member, providing a fluid at the distalend of the inner tubular member, withdrawing a fluid at the distal endof the inner tubular member, providing a fluid at the distal end of theouter tubular member, withdrawing a fluid at the distal end of the outertubular member, inflating a balloon at the distal end of the innertubular member, inflating a balloon at the distal end of the outertubular member, delivering and inflating a balloon using the catheterdevice, delivering a stent using the catheter device, and delivering aprosthetic valve using the catheter device.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is an illustration of a catheter device constructed in accordancewith the present technology, where the catheter device is shown in itsinitial configuration with an outer tubular member in an AL1 cathetertip configuration;

FIG. 2 is an illustration of the catheter device with an inner tubularmember forming a pigtail configuration at the distal end, extending fromwithin the outer tubular member after manipulating the control handle tochange the tip shape;

FIG. 3 is an exploded-view illustration of the inner and outer tubularmembers in component form shown separated for clarity;

FIG. 4 is an exploded-view illustration of the control handle;

FIG. 5A is an alternative embodiment of the catheter device in aninitial configuration showing tip shape and handle position;

FIG. 5B is an alternative embodiment of the catheter device in a secondconfiguration showing tip shape and handle position;

FIG. 6 is an illustration showing an alternative embodiment of a portionof the control handle;

FIG. 7 is an illustration showing an alternative embodiment of a controlhandle configuration with a spring-loaded detent system actuated by adepressible release button;

FIG. 8 is an illustration showing an alternative embodiment of a controlhandle with undulations on the outer surface of the circular controlring;

FIG. 9 is a cross sectional illustration showing a view of the controlhandle, where dashed lines depict a fluid flow path from a side port;

FIGS. 10 A/B/C/D/E show the catheter device in the anatomy in variousconfigurations;

FIG. 11 is an illustration of the catheter device shown with a view ofthe slot in the control handle mechanism that limits movement of theouter tubular member; and

FIG. 12 is a flowchart diagram of a method for employing the disclosedcatheter devices shown in FIGS. 1-11.

DETAILED DESCRIPTION

The following description of technology is merely exemplary in nature ofthe subject matter, manufacture and use of one or more inventions, andis not intended to limit the scope, application, or uses of any specificinvention claimed in this application or in such other applications asmay be filed claiming priority to this application, or patents issuingtherefrom. Regarding methods disclosed, the order of the steps presentedis exemplary in nature, and thus, the order of the steps can bedifferent in various embodiments. “A” and “an” as used herein indicate“at least one” of the item is present; a plurality of such items may bepresent, when possible. Except where otherwise expressly indicated, allnumerical quantities in this description are to be understood asmodified by the word “about” and all geometric and spatial descriptorsare to be understood as modified by the word “substantially” indescribing the broadest scope of the technology. “About” when applied tonumerical values indicates that the calculation or the measurementallows some slight imprecision in the value (with some approach toexactness in the value; approximately or reasonably close to the value;nearly). If, for some reason, the imprecision provided by “about” and/or“substantially” is not otherwise understood in the art with thisordinary meaning, then “about” and/or “substantially” as used hereinindicates at least variations that may arise from ordinary methods ofmeasuring or using such parameters.

All documents, including patents, patent applications, and scientificliterature cited in this detailed description are incorporated herein byreference, unless otherwise expressly indicated. Where any conflict orambiguity may exist between a document incorporated by reference andthis detailed description, the present detailed description controls.

Although the open-ended term “comprising,” as a synonym ofnon-restrictive terms such as including, containing, or having, is usedherein to describe and claim embodiments of the present technology,embodiments may alternatively be described using more limiting termssuch as “consisting of” or “consisting essentially of” Thus, for anygiven embodiment reciting materials, components, or process steps, thepresent technology also specifically includes embodiments consisting of,or consisting essentially of, such materials, components, or processsteps excluding additional materials, components or processes (forconsisting of) and excluding additional materials, components orprocesses affecting the significant properties of the embodiment (forconsisting essentially of), even though such additional materials,components or processes are not explicitly recited in this application.For example, recitation of a composition or process reciting elements A,B and C specifically envisions embodiments consisting of, and consistingessentially of, A, B and C, excluding an element D that may be recitedin the art, even though element D is not explicitly described as beingexcluded herein.

As referred to herein, disclosures of ranges are, unless specifiedotherwise, inclusive of endpoints and include all distinct values andfurther divided ranges within the entire range. Thus, for example, arange of “from A to B” or “from about A to about B” is inclusive of Aand of B. Disclosure of values and ranges of values for specificparameters (such as amounts, weight percentages, etc.) are not exclusiveof other values and ranges of values useful herein. It is envisionedthat two or more specific exemplified values for a given parameter maydefine endpoints for a range of values that may be claimed for theparameter. For example, if Parameter X is exemplified herein to havevalue A and also exemplified to have value Z, it is envisioned thatParameter X may have a range of values from about A to about Z.Similarly, it is envisioned that disclosure of two or more ranges ofvalues for a parameter (whether such ranges are nested, overlapping ordistinct) subsume all possible combination of ranges for the value thatmight be claimed using endpoints of the disclosed ranges. For example,if Parameter X is exemplified herein to have values in the range of1-10, or 2-9, or 3-8, it is also envisioned that Parameter X may haveother ranges of values including 1-9, 1-8, 1-3, 1-2, 2-10, 2-8, 2-3,3-10, 3-9, and so on.

When an element or layer is referred to as being “on,” “engaged to,”“connected to,” or “coupled to” another element or layer, it may bedirectly on, engaged, connected or coupled to the other element orlayer, or intervening elements or layers may be present. In contrast,when an element is referred to as being “directly on,” “directly engagedto,” “directly connected to” or “directly coupled to” another element orlayer, there may be no intervening elements or layers present. Otherwords used to describe the relationship between elements should beinterpreted in a like fashion (e.g., “between” versus “directlybetween,” “adjacent” versus “directly adjacent,” etc.). As used herein,the term “and/or” includes any and all combinations of one or more ofthe associated listed items.

Although the terms first, second, third, etc. may be used herein todescribe various elements, components, regions, layers and/or sections,these elements, components, regions, layers and/or sections should notbe limited by these terms. These terms may be only used to distinguishone element, component, region, layer or section from another region,layer or section. Terms such as “first,” “second,” and other numericalterms when used herein do not imply a sequence or order unless clearlyindicated by the context. Thus, a first element, component, region,layer or section discussed below could be termed a second element,component, region, layer or section without departing from the teachingsof the example embodiments.

Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,”“lower,” “above,” “upper,” and the like, may be used herein for ease ofdescription to describe one element or feature's relationship to anotherelement(s) or feature(s) as illustrated in the figures. Spatiallyrelative terms may be intended to encompass different orientations ofthe device in use or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.Thus, the example term “below” can encompass both an orientation ofabove and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein interpreted accordingly.

The present technology provides ways to access one or more preciselocations within a body of a patient using a catheter device and effectan easy and fast shape change at a distal end of the catheter device,thereby reducing a number of catheters and/or devices required for agiven intervention, providing optimal control for an interventionalist,and simplifying an intervention procedure experienced by the patient.Methods of using a concentric two-tube catheter device including aninner tubular member and an outer tubular member are provided thatinclude slidably disposing one of the inner tubular member and the outertubular member relative to the other one of the inner tubular member andthe outer tubular member to expose a distal end of the inner tubularmember from a distal end of the outer tubular member. The distal end ofthe outer tubular member provides a first shape, the distal end of theinner tubular member provides a second shape upon exposure thereof,where the first shape and the second shape are different. For example,the first shape can have less curvature than the second shape and/or thefirst shape can have a shorter curved length than the second shape. Theinner tubular member can be slidably disposed to extend from the outertubular member to expose the distal end of the inner tubular member fromthe distal end of the outer tubular member and/or the outer tubularmember can be slidably disposed to retract from the outer tubular memberto expose the distal end of the inner tubular member from the distal endof the outer tubular member. In this way, the catheter device can beused to access a desired location within a body and effect a change to adistal tip shape of the catheter device, where the ability to change thedistal tip shape can provide a shape optimal for insertion/withdrawal ofthe catheter device and a shape optimal for an intervention at thedesired location.

The present technology can include aortic valve no exchange cathetersand concentric two-tube catheter devices as described by U.S. patentapplication Ser. No. 15/907,456 to Ramanathan filed Feb. 28, 2018, whichis incorporated herein by reference.

Examples of catheter systems and devices useful in performing themethods and procedures described herein can include the followingstructural features and functionalities. A catheter system can includean inner tubular member and an outer tubular member with an attachedcontrol handle mechanism. The inner tubular member and outer tubularmember can also referred to as an inner catheter and an outer catheter.The outer tubular member can be advanced or retracted relative to theinner tubular member, the advancement or retraction controlled by acontrol handle mechanism. One or both of the inner tubular member andthe outer tubular member can be pre-curved or, in other words, processedor configured to assume a non-linear shape. It is also possible that oneor both of the inner tubular member and the outer tubular member caninclude one or more straight portions. The control handle can bedesigned to provide precise and repeatable movement of the outer tubularmember relative to the inner tubular member. This can permit a change incatheter form and minimizes effort needed by an operator to make one ormore changes to a shape of a distal portion of the catheter whileperforming a procedure.

The inner tubular member can have a resilience to adapt to a pre-curvedshape of the outer tubular member when the outer tubular member isextended over a distal tip of the inner tubular member. This shapechange feature can facilitate access to a treatment site, providing foran first configuration optimized to access the treatment site and asecond configuration optimized for use at the treatment site. Thissystem is designed to eliminate a catheter exchange and the need formultiple guide wire exchanges used to facilitate catheter exchanges.

The catheter device can include a relatively long inner tubular memberas compared with the outer tubular member. The outer tubular member canbe extended completely over the distal tip of the inner tubular member.The outer tubular member can be constructed with a stiffness thatconforms the shape of the inner tubular member to that of the outertubular member. The distal end of the outer tubular member can be shapedto optimize access to the left ventricle or another target site. Acontrol handle can enable precise and repeatable movement of the outertubular member resulting in a shape change from an initial tip shapeconfiguration to a final tip shape configuration, by exposing the innertubular member without distraction or undue manipulation. This can beaccomplished by permitting a defined range of travel that can begoverned by a distal stop, a movable range, and a proximal stop. Thispredefined range of motion can enable the operator to make tip shapechanges easily and without the need for fluoroscopic visual confirmationand without the need for the operator to visually observe the handlewhen making a change.

The catheter device can also be configured to deliver one or more otherdevices into one or more other areas of the body, for example, into theleft atrial chamber of the heart through a septal puncture, or intocoronary arteries. More broadly, the catheter device can replacenumerous devices needed to gain access to a specific location in theanatomy. The position of the control handle distal stop, allowable rangeof motion, and proximal stop are adjusted to suit a specificapplication. It can also be advantageous to reverse the direction of thecatheter system movement, where instead of retracting the outer tubularmember to expose the inner tubular member, to where the inner tubularmember is extended past the end of the outer tubular member.

The control handle can precisely control the shape change of thecatheter in repeatable manner. The range of motion of the outer tubularmember can be constrained. This can be controlled by the allowabletravel designed into the handle. In limiting the range of relativepositioning, the operator can therefore facilitate a fast exchange, in acontrolled manner, from a first configuration to a second configuration.A positive lock and/or detent mechanism can be incorporated into thecontrol handle to secure the device in a desired configuration until theoperator desires to change the catheter distal shape. The handle controlmechanism can be optimized to provide a long range of movement in asmall efficient package.

The outer tubular member can have a side port configured to fluidlycommunicate with the lumen of the outer tubular member. In this way, thelumen can be flushed with saline or other fluids. A vacuum can also beapplied through the side port to remove air or other gas bubbles fromthe lumen of the outer tubular member to prevent air ingress into theblood circulation system.

A pressure transducer or a separate port engaged with a pressuretransducer can be connected to the outer tubular member side port. Theside port can have a threaded interface to ensure a secure and leak-freeconnection to other accessories. In other embodiments, the pressuresensor can be mounted near or at the distal end of the outer tubularmember to make a more direct measurement of blood pressure. This canhelp overcome any deleterious dampening effects from trying to measurepressure through a small lumen in a catheter. In other words, thepressure signal can weaken over distance making the signal to noiseratio worse. In other embodiments, a dedicated lumen can be incorporatedinto a space between the outer tubular member and inner tubular memberto provide a channel for blood to be in fluid communication with anexternal pressure sensor, where the dedicated lumen can reduce anypressure dampening effects that a small clearance between tubularmembers might create. In other embodiments, a micro-electronicmechanical (MEMs) pressure sensor can be integrated at the end of theouter tubular member to provide high fidelity pressure measurements.

An access port can be attached to a proximal most portion of the innertubular member to enable delivery of other devices (e.g., one or moreguide wires) or fluid (e.g., sterile saline). Alternatively, a pressuretransducer and/or a separate port engaged with a pressure transducer canbe connected to the proximal port. The proximal port described can havea threaded interface to ensure a secure and leak-free connection toother devices/accessories or to fluids.

The control handle can incorporate o-rings or other sealing means toseal the lumen of the outer catheter while still preserving its abilityto be slid over the inner elongate tubular member. The O-rings or othersealing means can be incorporated into a housing that also serves toretract and, subsequently, advance the outer tubular member over theinner tubular member.

To enhance performance in certain embodiments, the control handle can beconfigured to retract the outer tubular member, rather than extend theinner tubular member. This operation can be provided to preventundesired contact or injury within the left ventricle, for example.There are vulnerable structures, for example, such as papillary muscles,chordae tendineae, mitral valve leaflets, and other tissues oranatomical locations that can be damaged by inadvertent extension of thecatheter.

Additional examples of catheter devices useful in performing the methodsand procedures described herein can include the following structuralfeatures and functionalities. Concentric two-tube catheter devices canbe employed where such devices include an inner tubular member, an outertubular member, and a handle assembly. The inner tubular member can havea proximal end attached to a handle body and a distal end with a tipshape configured for a particular medical procedure. The outer tubularmember can be concentric with and slidably disposed upon the innertubular member, where the outer tubular member can have a proximal endattached to a control ring and a tip shape configured for placement ofthe catheter device in a patient. The handle assembly can include thehandle body and the control ring, where the control ring can be slidablydisposed upon the handle body. Positioning the control ring at a distalend of the handle body can cause the outer tubular member to be extendedand cover the inner tubular member and positioning the control ring at aproximal end of the handle body can cause the outer tubular member to beretracted and expose the distal end of the inner tubular member. Theouter tubular member can have a bending stiffness greater than that ofthe inner tubular member, where such causes the tip shape of the innertubular member to conform to the tip shape of the outer tubular memberwhen the inner tubular member is covered by the outer tubular member.

Such catheter devices can further include the following features andaspects. One or more side ports can be coupled to the control ring,where the side port(s) can be in fluid communication with an annularspace between the outer tubular member and the inner tubular member. Anend port can be coupled to a proximal end of the handle body that is influid communication with an interior of the inner tubular member. Afirst pressure transducer can be coupled to the end port, where thefirst pressure transducer can be configured to monitor a pressure at thedistal end of the inner tubular member. A second pressure transducercoupled to a side port, where the second pressure transducer can beconfigured to monitor a pressure at the distal end of the outer tubularmember. The first pressure transducer and the second pressure transducercan each provide a signal to a display device for visual display. Afirst fluid line can be coupled to the end port and/or a second fluidline can be coupled to the side port, where the first fluid line and thesecond fluid line are each configured to provide a fluid to, or withdrawfluids from, a distal end of the respective inner tubular member andouter tubular member. The inner tubular member and the end port can beconfigured to permit a guide wire to be inserted into the end port andadvanced to and through the distal end of the inner tubular member.

In certain embodiments, a hypotube can be included that concentricallysurrounds a proximal end of the inner tubular member inside the handlebody. A flexible slider tube can couple the proximal end of the outertubular member to the control ring, where the flexible slider tubeconcentrically surrounds and is slidable relative to the hypotube. Thehypotube can be constructed of stainless steel, for example.

Catheter devices can further include where one or both of the innertubular member and the outer tubular member has/have a plurality ofholes formed through a tube wall near a distal end thereof. A slot canbe provided in the handle body, where the slot is configured to definelimits of travel of the control ring. A distal end of the slot cancorrespond to a control ring position that causes the outer tubularmember to be extended to a position covering the distal end of the innertubular member and a proximal end of the slot can correspond to acontrol ring position that retracts the outer tubular member and exposesa desired length of the distal end of the inner tubular member. Alocking feature can be included in the handle body that allows lockingthe control ring in a position relative to the handle body. The lockingfeature can include a slot segment at each end of the slot, where theslot segments are oriented perpendicular to the slot and allow thecontrol ring to be rotated into a locked position.

A radiopaque material can be provided in at least a portion of the innertubular member and/or at least a portion of the outer tubular member,where the radiopaque material improves visibility of the respectiveportions of the catheter device under fluoroscopy or x-ray.

In certain embodiments, the inner tubular member and the outer tubularmember each comprise a proximal segment and a distal segment, where eachproximal segment has a greater bending stiffness than the respectivedistal segment. The tip shape of the outer tubular member can include ahook shape configured for advancing the outer tubular member to andacross an aortic valve of a patient's heart. The tip shape of the innertubular member can include a pigtail shape configured for performing aprocedure in a ventricle of the heart.

The catheter systems and devices described herein can be used in variousmethods, including various treatments, surgical procedures, andinterventions. Certain embodiments of such methods provide particularbenefits and advantages in relation to the changing of a shape of adistal portion of a catheter device, including changing the shape of thedistal portion of the catheter device located within a patient, such aswithin a blood vessel or an organ such as the heart. Such catheterdevices can be used to overcome certain issues facing catheter insertioninto a body cavity, duct, or vessel to treat a medial condition ordisease or to perform a surgical procedure. In particular, there is anunmet need in interventional cardiology for percutaneous coronaryintervention guide catheters that can access a portion of thevasculature in an optimal shape, and subsequently change to a moresupportive configuration when the catheter arrives at the target vessel,in order to provide an advantage to the interventional cardiologistperforming the procedure and thereby improve the procedure for thepatient. For example, an interventional cardiologist may choose anaggressive or complex shaped guide catheter for percutaneous coronaryintervention of the right coronary artery such as an AL1 guide; however,this aggressive or complex guide shape can lead to complications such asdissection of the right coronary artery or injury to the aorta. Findinga catheter that can optimally engage the ostium of the right coronaryartery, but subsequently provide the support of an aggressive or complexshaped guide catheter such as the AL1 would be advantageous for both theinterventionalist and the patient. Furthermore, in diagnosticcatheterization, radial use has become more frequent due to lessvascular complications.

A single catheter is often employed to minimize the number of catheterexchanges, which can reduce the risk of radial artery spasm. Catheterscan be used to engage both the left and right coronary artery ostium fordiagnostic angiography, but such catheters can employ aggressive orcomplex shapes and can lead to injury of the vessel. In clinicalscenarios, including complex percutaneous coronary intervention anddiagnostic radial catheterization, there is accordingly a need forcatheters that can change shapes in an easy and seamless fashion whenrequired, where the present technology provides catheter devices anduses thereof that can meet this need.

For complex percutaneous coronary intervention, an interventionalcardiologist can be faced with choosing either an aggressive shapedguide catheter or use of another catheter within a catheter foradditional support to deliver a stent. The present technology provides asolution to this problem. A guide catheter is provided that can have astandard shape to accurately engage the ostium of a coronary artery,where the catheter device is configured so that, if necessary, theinterventionalist has the ability to advance a guide catheter that is 1French size smaller further down the vessel. For example, for a complexpercutaneous coronary intervention case, with a tortuous right coronaryartery or a chronic total occlusion of the right coronary artery, theinterventionalist may need to choose a guide catheter so that, ifnecessary, additional support can be provided.

The present technology therefore allows one to use a standard techniqueto engage the right coronary artery. If additional support is required,then one can advance a support catheter that is within the handle of thecatheter device by advancing a sliding mechanism forward; e.g., wherethe handle can be advanced from a first or initial position to a secondor final position. The mechanism of use for the present catheter deviceguide handle can be configured in a unique way, as rather thanretracting the outer catheter, the inner catheter can be advanced. Thehandle can be advanced, for example, following introduction of acoronary wire (e.g., 014) through the coronary artery and across astenosis. For further improvement, one can also advance a coronaryballoon dilatation catheter down the wire, and then advance the guideextender (e.g., advancing the handle from a first or initial position toa second or final position) down the coronary artery. The guide extendercan be contained in a compact fashion inside the small and compacthandle. Furthermore, the guide handle can allow the guide extender to behoused in a compact fashion, and when extended, it can telescope out10-20 cm, for example. With the 10 cm configuration, the handle can besmaller and more compact and can be ideal for a complex stenosis in theproximal to mid vessel. For a 20 cm extension configuration, the handlecan be slightly larger in diameter to house the guide extender. Incertain embodiments, the outer tubular member or outer catheter can be 1French size larger than the inner tubular member or inner catheter;e.g., if the outer tubular member size is 6 F, the inner tubular membersize can be 5 F. The handle can be extended and retracted as needed. Thehandle can include a locking mechanism to stay in a stable position sothat if it is advanced only 7 cm of the total 10 cm, it can stay in thatposition. Furthermore, the inner tubular member or inner catheter canhave a low pressure balloon that can be inflated to provide even greatersupport for the complex percutaneous coronary intervention procedure.

Advantages over existing guide extension catheters include the fact thatthe catheter device essentially includes an extending support catheterwithin it, minimizing the number of devices required. Furthermore, useof the present catheter device can be easier than introducing anadditional catheter as the workflow is smoother for a physician as thereis less equipment coming out of the backend of the catheter device.Furthermore, there are less exchanges and devices required with thepresent catheter device for complex percutaneous coronary interventionthan with other devices.

The present technology further includes use of catheter devices inradial catheterization. Use of radial catheterization has increased fordiagnostic catheterization in order to reduce complications associatedwith other techniques. For example, a single catheter is often employedto minimize the number of catheter exchanges, which can reduce the riskof radial artery spasm. Likewise, catheters exist to engage both theleft and right coronary artery ostium for diagnostic angiography, butthese have aggressive shapes and can lead to injury of the vessel. Thepresent technology presents a solution to these problems, as a singlecatheter device is provided that can possess a standard JR and JL shapeto optimally engage the ostium of the right coronary artery with the JRshape and the left coronary artery with the JL shape.

Embodiments of the present catheter devices and uses thereof include acombination of an inner tubular member (e.g., configured as 5 F JR4diagnostic catheter) and an outer tubular member (e.g., configured as a6 F JL4 diagnostic catheter). The inner tubular member can be containedwithin the outer tubular member, where the outer tubular member can beretracted using the handle mechanism, to thereby expose the innertubular member (e.g., configured as 5 F JR4 diagnostic catheter). Onecan use a 0.035 wire, for example, to advance the catheter device intothe ascending aorta and then with the outer tubular member (e.g.,configured as 6 F JL4 diagnostic catheter) engage the left coronaryartery. Once angiography is complete, one can remove the catheter devicefrom the left coronary artery, and retract the outer tubular member toexpose the inner tubular member (e.g., configured as 5 F JR 4) using thehandle. Once the inner tubular member (5 F JR 4) is exposed, the innertubular member can be used to engage the ostium of the right coronaryartery. The handle structure and operation can be configured as thehandle described herein and can operate in the same fashion. In certainembodiments, the catheter device does not need a pressure measuring portfor the outer catheter.

The present technology further provides methods of accessing a targetregion of cardiac tissue, including the arteries and the major chambersof the heart. Such methods can include providing a medical instrumentsuch as a catheter. Access to an artery in the body, such as the radialor femoral artery, is then created. A guide wire is inserted into theaccessed artery and the guide wire is advanced from the access arteryinto a target region of the heart. A medical instrument, including adual lumen catheter having inner and outer tubular members coaxiallyaligned substantially along a length of the catheter device, is extendedover the guide wire so that the catheter device is advanced to thetarget region of the heart. The control handle is manipulated to extendor retract one of the tubular members so that the other tubular memberis extended or exposed such that a proximal segment of the catheter isdual lumen and a distal segment is a single lumen catheter. The distaltip shape of the catheter device thereby changes from one configurationto a different configuration.

EXAMPLES

Example embodiments of the present technology are provided withreference to the several figures enclosed herewith.

With reference to FIG. 1, a no exchange catheter system 101 is shownthat benefits by reducing the need to remove and exchange variouscatheters and guide wires during a medical procedure. Shown in FIG. 2 isthe no exchange catheter system 101, comprised of an inner tubularmember 203 within an outer tubular member 103 each attached to separatecomponents of a control handle 105 approximately at their proximal ends.As discussed below, the outer tubular member 103 is slidably extensibleand retractable over the inner tubular member 203, controlled by thecomponents of the control handle 105.

The inner tubular member 203 is longer than the outer tubular member103. In exemplary fashion, an inner tubular member 203 may have apigtail shape 205 at its distal end 206, and may be “5 F” (meaning 5 onthe French scale, which equates to a diameter of 1.667 mm), and 110 cmlong. The outer tubular member 103 may have an AL1 (a particular type oftip) shape at its distal end 107, and can be 6 F (2 mm diameter), and is90 cm long. Other lengths and diameters are contemplated. For example,the total catheter length can be 125 cm and the range of movement of theouter tubular member 103 over the inner tubular member 203 can be 12 cm.For transcatheter aortic valve replacement procedures, the standardguide wire length of 260 cm dictates the total catheter system length beless than 130 cm, and preferably close to 130 cm. Other tip shapes mayalso be used as best suited for a particular application.

The control handle 105, at the proximal end of the catheter system 101,has a circular control ring 109 to facilitate movement of the outertubular member 103. When the operator pulls back the outer tubularmember 103 via sliding the circular control ring 109 back on the controlhandle 105, the distal end of the inner tubular member 203 is exposedand forms a pigtail shape when fully extended from the outer tubularmember 103. The linear range of motion of the outer tubular member 103can be 10 to 20 cm. Other distal inner tubular member shapes arecontemplated and can be similarly exposed when the outer tubular member103 is retracted. Likewise, the range of linear travel for the outertubular member 103 can be optimized for other contemplated applicationssuch as converting a Judkins left catheter to a Judkins right catheterand utilizing a range of travel that is less than 10 cm. Alternatively,other applications may dictate a larger than 20 cm range of travel.

By design, the control handle 105 limits travel of the circular controlring 109 and thus the travel of the outer tubular member 103 over theinner tubular member 203. This is controlled in one embodiment by thedimensions of a slot 1101 in the control handle 105 as shown in FIG. 11.In some embodiments of the present technology, a control ring lockingfeature is used to temporarily fix the position of the outer tubularmember 103 relative to the inner tubular member 203, where the cathetershape can be locked into position only when the outer tubular member 103is fully extended or fully retracted. Referring to FIG. 6, a slotsegment 607 extending 90 degrees from a longitudinal travel slot 601 isprovided to immobilize a circular control ring 603 at the extreme limitof the circular control ring travel. The circular control ring 603performs the same function as the circular control ring 109—that is,controls the position of the outer tubular member 103 relative to theinner tubular member 203. When at either of two extreme positions, thecircular control ring 603 can be rotated to lock the position of thecatheter. In FIG. 6, the control ring 603 covers another of the slotsegments 607 which is at the distal end of the longitudinal slot 601.Alternatively, the slot 1101 of FIG. 11 or a hard stop (not shown) builtinto the handle can preclude axial movement, forward and backwards, inplace of a twist lock mechanism.

The circular control ring 603 is shown in FIG. 6 as having a knurledouter surface. FIG. 8 shows a control ring with outward facingundulations 801 or other features designed to enhance grip for operatorswearing gloves.

FIG. 1 depicts the device in the initial configuration, shown here as anAmplatzer AL1 tip shape. Alternatively, the shape of the distal segmentmay be that of an Amplatzer AL2 or any other shape an operator prefersto gain access to a particular area of the anatomy. The outer tubularmember 103 has been extended to cover the distal end of the innertubular member 203 (thus the inner tubular member 203 is not visible inFIG. 1), and the distal tips of the inner tubular member 203 and outertubular member 203 are aligned. In this position, the distal shape ofthe catheter is governed by the shape of the outer tubular member 103. Aluer 111 is fused to the proximal most edge of the inner tubular member203, thereby allowing a fluidic coupling to the proximal end of theinner tubular member 203. The fluidic coupling provided by the luer 111may be used to monitor pressure in the inner tubular member 203, ordeliver a fluid through the inner tubular member 203, for example. InFIG. 1, the circular control ring 109 is in its distal most position,relative to the handle 105; this position of the circular control ring109 is what causes the outer tubular member 103 to be fully extendedover the inner tubular member 203.

A side port assembly 113 is attached to the circular control ring 109and is able to fluidly communicate with the space between the innertubular member 203 and the outer tubular member 103, regardless of theposition of the circular control ring 109. The fluid communication spaceis sealed using O-rings or other sealing means, discussed below. TheO-rings are designed to slide along with the circular control ring 109.

FIG. 2 depicts the device with the pigtail section 205 shown at thedistal end 206 of the inner tubular member 203. In this configuration,the outer tubular member 103 has been fully retracted to expose thedistal end of the inner tubular member 203. The inner tubular member 203can be longer than the outer tubular member 103. Hence, in thisconfiguration of FIG. 2, a section of the inner tubular member 203 isextended from the outer tubular member 103. The circular control ring109 is in its proximal most position in this configuration, which iswhat caused the outer tubular member 103 to retract and expose theportion of the inner tubular member 203. A distal tip 106 of the outertubular member 103 is denoted on FIG. 2; this is the point at which theinner tubular member 203 emerges from the outer tubular member 103.

FIG. 3 depicts the inner tubular member 203 and the outer tubular member103 as separated, with each showing an exemplary tip shape. The innertubular member 203 is made from a relatively flexible polymericmaterial, one that conforms to the shape of the outer tubular member 103when inserted into the outer tubular member 103. The polymeric innertubular member 203 is made from a soft material such as a thermoplasticelastomer. One such soft material is a polyether block amide and has alow durometer value, for example, 35-55 Shore D. An example of thepolyether block amide is sold under the trademark PEBAX®. Other polymerssuch as thermoplastic polyurethanes with similar softness and similardurometer ranges are also contemplated. These materials are well knownto those skilled in the art. The wall of the inner tubular member 203 ismade deliberately thin, for example in a range of 0.003″ to 0.007″. Thepreferred wall thickness is approximately 0.005″. The thin wallthickness facilitates shape conformance of the inner tubular member 203to the outer tubular member 103.

The polymeric outer tubular member 103 is made from a relatively stiffermaterial than the inner tubular member 203. This can be accomplishedusing a higher durometer polymer, relative to the inner tubular member203. A polymeric material such as a polyether block amide in a range ofdurometers such as 55-76 Shore D are suitable. An example of thepolyether block amide is sold under the trademark PEBAX®. Other polymerssuch as thermoplastic polyurethanes with similar softness and similardurometer ranges are also contemplated.

The stiffness of the individual tubular members can be varied using oneor more of several techniques including selecting and/or mixing polymersof differing hardness, adjusting the tubing wall thickness,incorporating a stainless steel braid reinforcement, and/or using amulti-layer tubing design.

Typical intravascular catheters can be comprised of two sections, namelya proximal and distal section. These two sections are fused together toform one complete catheter. However, each section is designed to performa different function. For example, the first, or proximal section, tendsto be straight and stiff to enable advancement of the catheter to atarget region. The second, or distal section, is typically softer andshaped to engage the anatomy. It is a common practice to utilizedifferent stiffness grades of the same basic polymer material tofabricate the proximal and distal segments of each tubular member.

The inner tubular member 203 of the present technology is comprised of afirst section 221 and a second section 222, wherein the first section221 is a generally elongated straight section which is connected at itsdistal end with the second section 222, which is a curved section suchas a pigtail configuration.

Similarly, the outer tubular member 103 of the present technology iscomprised of a first section 121 and a second section 122, wherein thefirst section 121 is a generally elongated straight section which isconnected at its distal end with the second section 122 that forms acompound curve designed to easily access the aortic valve and providepassage to the left ventricle. An example of a distal shape may be anAmplatzer AL1.

FIG. 4 shows the major components of the control handle assembly in anexploded view. In short, the handle assembly provides for a slidable andleak free outer tubular member 103 configured to slide over a reinforcedinner tubular member 203. The outer tubular member 103 is attached to acontrol handle mechanism enabling the operator to retract or advance theouter tubular member 103. A distal end 401 of the inner tubular member203 may be inserted through the handle components for assembly. Astainless steel hypotube 402 is inserted over the inner tubular member203, is used to reinforce the inner tubular member 203, and functions toprevent unwanted bending or kinking of the inner tubular member 203during handle manipulation.

A sealing means such as an O-ring, a plurality of O-rings, or ahemostasis valve, adapted for sliding along a stiff, reinforcing memberenables relative movement of the inner tubular member 203 and outertubular member 103 while continuously providing a blood hemostasis seal.O-rings 403 are used to seal the proximal most portion 410 of the outertubular member 103, which in turn, is fused to a flexible slider tube405. This ensures a leak free system enabling the inner tubular member203 and the outer tubular member 103 to be slidable in relation to eachother.

A main body 404 within the circular control ring houses the O-rings 403and provides for a sealed fluid path (dashed line in FIG. 9) from theproximal segment 410 of the outer tubular member 103 to the side port408. A flexible slider tube 405 is inserted into the proximal segment410 of the outer tubular member 103. This enables the distal end 401 ofthe inner tubular member 203 and the stainless steel hypotube 402 to fitwithin the flexible slider tube 405. An adhesive bond with an adhesivefillet 411 provides a leak-free seal between the flexible slider tube405 and the proximal segment 410 of the outer tubular member 103 afterassembly.

The control handle mechanism housing 406 has a slot (FIG. 11, 1101)providing a fixed range of travel for the control ring 109. The controlhandle mechanism housing 406 is made in two halves, which when assembledare joined using adhesive or fasteners. The control handle mechanismhousing 406 houses the distal end 401 of the inner tubular member 203and provides the operator with a feature to grip the catheter. A luer407 is bonded to the proximal end of the inner tubular member 203 andprovides a means to couple the inner tubular member 203 to accessoriessuch as a syringe or a Touhy Borst connector (not shown).

The circular control ring 413 (same as control ring 109) is assembledfrom two halves bonded together and provides the operator with an easyto grip surface to manipulate the position of the outer tubular member103. The circular control ring 109 attaches to the handle controlmechanism 105 as shown in FIG. 1. This assembly, in turn, houses O-rings403, an O-ring slider mid-body 414, and O-ring slider end cap 415, andmaintains the O-rings in position. Dowel pins 412 can be used to fastenthe circular control ring halves 413 together immobilizing thecomponents in the circular control ring 109. A side port tubing 409connects the side port 408 to the proximal segment 410 of the outertubular member 103, to enable a leak free fluid communication path fromthe side port 408 (or 113 in FIG. 1) to the outer tubular member 103.

FIG. 9 is a cross-sectional illustration of the control handle assemblyshowing many of the same elements as FIG. 4. The following discussion isprovided to summarize the operation of the tubular members and thecontrol handle assembly as depicted in FIGS. 1, 2, 4 and 9. The keypoint is that the inner tubular member 203 is fixed relative to thecontrol handle 105, while the outer tubular member 103 slides relativeto the inner tubular member 203 based on movement of the control ring109 along the control handle 105 (FIGS. 1 & 2). After assembly, theinner tubular member 203 is fixed in longitudinal position relative tothe control handle 105, which is embodied primarily in the two halves ofthe control handle mechanism housing 406. The hypotube 402 supports theinner tubular member 203 to prevent kinking, and the luer 407 allows afluidic coupling to the inside of the inner tubular member 203. Theouter tubular member 103 slides longitudinally relative to the innertubular member 203 and the control handle 105, driven by the position ofthe control ring 109, which is embodied primarily in the circularcontrol ring halves 413 and the control ring main body 404. The flexibleslider tube 405 transfers motion of the control ring 109 to the outertubular member 103 itself. The flexible slider tube 405 slides over thehypotube 402 within the handle assembly. The annular space between theinner tubular member 203 and the outer tubular member 103 is in fluidcommunication with the side port tubing 409 and the side port 408, asshown in FIGS. 4 and 9.

FIG. 5a shows a depiction of an embodiment of the currently disclosedcatheter system in an initial configuration and FIG. 5b shows the samecatheter system in a second configuration. FIGS. 5-8 depict differentembodiments than the figures discussed previously, where in particular,the embodiments of FIGS. 5-8 include handle features for locking theextension/retraction position of the outer tubular member 103 relativeto the inner tubular member 203, but do not include a side port. FIGS. 5a/b include a control handle 605 and a control ring 603. As in earlierembodiments, longitudinal motion of the control ring 603 along thehandle 605 moves the outer tubular member 103 relative to the innertubular member 203. The position of the control ring 603 is shown inboth an initial configuration (FIG. 5a , where the outer tubular member103 is fully extended over and covers the inner tubular member 203) anda second configuration (FIG. 5b , where the control ring 603 and theouter tubular member 103 have been retracted, exposing the pigtail 205at the distal end 206 of the inner tubular member 203). The position ofthe control ring 603 controls the exposed amount of the inner tubularmember 203, which in turn correlates to the configuration of thecatheter tip, thus providing a visual cue to the operator of the distaltip configuration.

FIG. 6 shows the control handle 605 detached from the catheter. In thisembodiment of the control handle mechanism, the range of travel isdictated by a slot 601 in the handle housing. The slot 601 may include alocking feature, a slot segment 607 extending 90 degrees from thelongitudinal travel slot 601, at the proximal and distal (not shown)extremes of travel to provide for a twist lock mechanism to immobilizethe circular control ring 603 and thus preventing unwanted catheter tipshape changes.

FIG. 7 shows a control handle 705 which includes a spring-loaded detentsystem actuated by a depressible release button 703 that may provideadditional means to lock the catheter into position. The button 703 is acontrol element which replaces the control ring 603 of FIG. 6, and theouter tubular member 103 is attached to the button 703 for adjustment ofthe position of the outer tubular member 103. The button 703, whenpressed, may move along a slot 704. Releasing the button 703 locks thebutton 703 in place, which locks the position of the outer tubularmember 103 relative to the inner tubular member 203.

FIG. 8 shows the handle 605 with undulations 801 on the outer surface ofthe control ring 603, rather than the knurled surface of FIG. 6, toenhance the grip of the operator. The arrows in FIG. 8 depict thelongitudinal travel of the control ring 603 relative to the handle 605,and rotation of the control ring 603 into the slots 607 at either end ofthe range of travel.

The handle embodiments of FIGS. 6-8 are shown to illustrate the outertubular member 103 adjustment and locking features. For the sake ofclarity and simplicity, these handle embodiments are not shown withadditional features such as the side port 113 and the luer 111 of FIG.1—but the side port and luer features are equally applicable to any andall handle embodiments, including those of FIGS. 6-8.

FIGS. 10a-10e show the presently disclosed catheter system 101 in thehuman anatomy in various stages of insertion and the correspondingcatheter configuration. FIG. 10a shows the catheter system 101 beinginserted into an artery remote from the heart, such as in the upper leg.The lengths of the outer tubular member 103 and inner tubular member 203discussed previously are suitable for the catheter system 101 totraverse an artery all the way up to and into the heart.

FIG. 10b shows the catheter system 101 near a stenotic aortic valve ofthe heart. The distal end 107 of the outer tubular member 103, in an AL1configuration, is visible with a guide wire 1002 extending from theouter tubular member 103. In FIG. 10b , the catheter system 101 has beeninserted through the vasculature up to the aortic valve of the heart,and the outer tubular member 103 is still fully covering the innertubular member 203, corresponding to the position of the control ring109 at the distal end of the control handle 105. The guide wire 1002 isnext used to guide the catheter system 101 through (across) the aorticvalve into the ventricle. A plurality of holes 1050 may be providedthrough the wall of the outer tubular member 103 near its distal end107, where the holes 1050 facilitate improved fluid communication to theproximal (handle) end of the outer tubular member 103 and thereforebetter measurement of pressure and/or better flow of fluids through thecatheter system 101.

FIG. 10c shows the catheter system 101 in the left ventricle. In thisfigure, the outer tubular member 103 is still fully covering the innertubular member 203, as the position of the control ring 109 is still atthe distal end of the control handle 105. The distal end 107 of theouter tubular member 103 remains in AL1 configuration and is now in itsdesired location in the ventricular chamber, where the holes 1050facilitate blood pressure measurement by a sensor at the proximal end ofthe outer tubular member 103 (discussed below). FIG. 10c represents thestage in the procedure where the catheter system 101 has been insertedinto position with the gently curved tip shape of the outer tubularmember 103, the guide wire 1002 has been retracted, and the procedureinvolving the inner tubular member 203 is ready to begin.

FIG. 10d shows the catheter system 101 being transformed from an AL1configuration to a pigtail configuration by beginning retraction of theouter tubular member 103. It can be seen in FIG. 10d that the controlring 109 has been moved over halfway toward the proximal end of thecontrol handle 105, which causes the outer tubular member 103 to retractand expose part of the inner tubular member 203. The pigtail shape 205is now visible at the distal end 206 of the inner tubular member 203. Aplurality of holes 1060 may be provided through the wall of the innertubular member 203 near its distal end 206, where the holes 1060facilitate improved fluid communication to the proximal (handle) end ofthe inner tubular member 203 and therefore better measurement ofpressure and/or better flow of fluids through the catheter system 101.

FIG. 10e shows the catheter system 101 with the outer tubular member 103fully retracted back up above the aortic valve. It can be seen in FIG.10e that the control ring 109 has been moved all the way to the proximalend of the control handle 105, which has caused the outer tubular member103 to fully retract and expose a maximum amount of the inner tubularmember 203. The holes 1050 in the outer tubular member 103 are visibleabove the aortic valve, where they improve fluid communication betweenthe aortic location and the proximal end of the catheter system 101. Theholes 1060 in the inner tubular member 203 are visible in the leftventricle, where they improve fluid communication between theventricular location and the proximal end of the catheter system 101.

FIG. 10e also shows a pressure transducer 1012 mounted at the side port113, and a pressure transducer 1022 mounted at the luer 111 tofacilitate differential blood pressure measurements, and an insetshowing the pressure measurement as it might appear on a viewinginstrument. Recall that the luer 111 is in fluid communication with theinside of the inner tubular member 203, and the side port 113 is influid communication with the annular space between the outer tubularmember 103 and the inner tubular member 203. Thus, the pressuretransducer 1012 is measuring pressure at the tip of the outer tubularmember 103 above the aortic valve, and the pressure transducer 1022 ismeasuring pressure at the tip of the inner tubular member 203 in theventricular chamber. The transducer 1012 provides a signal to thedisplay 1030 via wire 1014, and the transducer 1022 provides a signal tothe display 1030 via wire 1024. Alternatively, the transducers maycommunicate wirelessly with the display and any related computermonitoring system.

FIG. 10e also shows a fluid tube 1010 passing through the pressuretransducer 1012 and a fluid tube 1020 passing through the pressuretransducer 1022. The fluid tube 1010 is connected to the side port 113and could be used to introduce a fluid to or withdraw a fluid from thetip of the outer tubular member 103, which in this case is above theaortic valve. The fluid tube 1020 is connected to the luer 111 and couldbe used to introduce a fluid to or withdraw a fluid from the tip of theinner tubular member 203, which in this case is in the ventricularchamber. Techniques are used to prevent air embolization in the bloodstream and air in the tubes 1010 and 1020.

Rather than the transducers 1012 and 1022 to measure blood pressure asshown in FIG. 10, the catheter system 101 may include a sensor mountednear the distal tip of the outer tubular member 103 and/or the innertubular member 203 to monitor blood pressure (not shown).

The inner tubular member 203 is comprised of a relatively stiff proximaltubular member that is adapted for the outer tubular member 103 to slideover it and have sufficient column strength to avoid buckling. Theproximal segment 221 of the inner tubular member 203 can be fused to amore flexible distal segment 222 by any number of means including heator adhesive bonding. The proximal segment 221 of the inner tubularmember 203 may be made of a braid reinforced polymer tubing capable ofwithstanding high internal pressures without failure. This facilitatesthe use of a pressure injection system for radiopaque contrast injectioninto the heart for imaging. The proximal segment 221 of the innertubular member 203 may be made from a stiffer material such as 304stainless steel or a reinforced polyimide tube. Alternatively, the innertubular member proximal segment 221 could have a reinforcing sleeve toprovide needed stiffness.

The diameter dimensions of the present technology at its proximal end,where it is reinforced or stiffened, can be different than the diameterdimensions, both inner and outer diameters, of the distal segment 222that enters into the patient or body.

The outer tubular member 103 similarly has a relatively stiffer proximalsegment 121 and a more flexible distal segment 122. The proximal segment121 is designed to withstand buckling as it is advanced and retractedover the outer diameter of the inner tubular member 203. Similar to theinner tubular member 203, the inner and outer diameter dimensions of thedistal segment 122 that enters into the body may differ from the portionthat interacts with or is in the handle control mechanism.

The catheter system 101 may come in two lengths, such as a standard 100cm, and a longer 125 cm catheter. Once the sterile catheter system isremoved from the sterile packaging, a 150 cm J-tipped guide wire can beinserted into the catheter system 101 (through the interior of the innertubular member 203) to allow placement of the catheter close to theaortic valve. Once in place, the 150 cm guide wire is removed and astandard 150 cm straight tipped guide wire is placed through the port orluer 111 attached to the base (proximal end) of the handle 105. Thisport or luer 111 can also enable measurement of left ventricularpressures as discussed above. This is accomplished by attaching anexternal pressure transducer to this port or, alternatively,incorporating a MEMS or optical pressure sensor into the catheter influid communication with the lumen connected to this port.

A second port, the sliding side port 113, is attached to the handleslide mechanism at the control ring 109 and is in fluid communicationwith the outer tubular member 103. This side port 113 enables the outertubular member 103 to be flushed with sterile saline or other fluidsthrough the lumen of the outer tubular member 103 (AL shaped catheter).This port also enables measurement of aortic pressures through the lumenof the outer tubular member 103 or AL shaped catheter. In yet anotherembodiment, additional side holes may be placed in the outer tubularmember 103 to facilitate more accurate, or less damped, pressuremeasurements.

Another application of the present technology is for radial PCI. Thisembodiment provides a single device that can optimally and predictablybe used in place of multiple devices for performing invasive radialangiography. The control handle mechanism converts the shape of thecatheter distal tip from one shape to another to perform as a diagnosticcatheter for angiography and then permit the outer tubular member 103 tobe retracted to expose the inner tubular member 203 to performcontralateral vessel angiography. In this respect, the control handlemechanism is similar to the transcatheter aortic valve application,although the method of use may vary between procedures. Advantageously,this configuration enables an initial tip configuration to facilitatenavigation through the body's vasculature system. When at the targetlocation, then the tip can be transformed to a more aggressive shape, tomore optimally perform the procedure in the coronary arteries. The moreaggressive tip shape of the inner tubular member 203, which may bewildly contoured and capable of causing injury during delivery, issheathed by an optimally shaped outer tubular member 103 until thedevice is advanced to the treatment zone. The risk of injury is reducedbecause an optimal shape is maintained during delivery.

An alternative embodiment for the present technology is for use ininterventional cardiology procedures, such as PCIs, where devices areinserted into occluded coronary arteries to reopen them and to provideblood to the heart. In difficult cases, known in the field as complexPCI, extra support is often needed to prevent the guide catheter frombacking out of the artery to be treated. In these situations whereadditional support is needed to deliver either a PTCA balloon or acoronary stent to the target lesion, the inner tubular member 203 isconfigured to be able to extend from within the outer tubular member 103into the coronary arteries. The present technology enables thiscapability faster and easier than the current approach of using multipledevices that require exchanges. In this embodiment, the outer tubularmember 103 would replace the function of a standard guide catheter,which typically is placed near the ostium of the vessel to be treated.The inner tubular member 203 is extended from the outer tubular member103 and is then advanced into the coronary artery to provide extrasupport. In these procedures, frequent catheter manipulations, includingrotating the device, makes it advantageous for the extended innertubular member 203 to be collapsed so it resides inside the handlecontrol mechanism. This eliminates the proximal segment from extendingover the hands of the operator and flopping around during devicemanipulation.

The previously described control handle mechanism can be used in thisapplication but the movement of the outer catheter would be in theopposite direction. The inner tubular member 203 is attached to andadvanced by the control handle mechanism to extend past the outertubular member 103. A handle embodiment may include provisions to enablea telescoping feature of the handle. This enables an original totalcatheter length (inner tubular member 203 and outer tubular member 103)that is desirably short for this procedure, for example 90 cm long. Whenutilizing the telescoping feature for the handle, the inner tubularmember 203 assembly is configured so that the telescoping handle can beinitially extended proximally (towards the operator and away from thepatient); then, during the procedure, the telescoping sections of thehandle can be collapsed, thus lengthening the inner tubular member 203so it may be extended past the outer tubular member 103. In a fullyextended position the device length can increase from 90 cm to 125 cm.There can be a means to limit the range of lengths of the inner tubularmember 203.

The telescoping feature can be comprised of multiple tubular membersdesigned to slide over each other in this handle embodiment. Eachtubular member has a specified diameter that enables it to be slidablypositioned over the underlying tubular member having a smaller diameter.There can be two such tubular members, which enable almost doubling thelength of the telescoping component of the handle. Additionally, morethan two tubular members may be employed in the same fashion to achievea greater change in length. The distal most tip of the telescopinghandle is attached to the proximal end of the catheter inner tubularmember 203. The attachment provides for a sealed lumen preventing a leakpath for air to enter into the body. A sealing means, such as O-rings,is used to ensure the telescoping handle mechanism is also sealed.

The present technology could be configured to have an inflatable balloonat its distal end to provide even more support. The balloon is attachedto either the inner tubular member 203 or the outer tubular member 103.Two balloons, one attached to each tubular member, is also contemplated.It is also advantageous to incorporate a discrete radiopaque markercomponent at the distal end of one or both of the tubular members103/203 so that the operator knows the position of the tip of thecatheter system 101 in the arterial anatomy. A radiopaque marker may bemade of platinum or a platinum alloy, such as 90% platinum and 10%iridium. There are other suitable radiopaque materials or alloys forthis function.

The present technology may also have the inner tubular member 203 andthe outer tubular member 103 loaded, or filled, with a dense radiopaquematerial to further improve visibility under fluoroscopy or x-raysystems. In this case, a material such as barium sulfate is added to thepolymers which ultimately are extruded into tubular form. The ratio ofthe additive to the parent tubing material may be 80% tubing materialand 20% radiopaque additive. Other ratios can be utilized to provideadequate imaging under fluoroscopy.

This embodiment of the present technology would also allow the use of abuddy wire system, which can be used for complex PCI. A buddy wiresystem is when an additional guide wire, is inserted along with theguide wire already in place, is employed through the guide catheter tohelp facilitate the procedure by providing extra stability or ananchoring function.

This particular embodiment would allow less imaging contrast to be usedfor complex PCI because there are fewer device exchanges and the innertubular member 203 is of a smaller diameter lumen, which permits lesscontrast needed for visualization. Reducing the use of radiopaquecontrast for imaging is beneficial to the patient and the hospital staffin the catheter lab.

The present technology simplifies currently practiced procedures byallowing for fewer catheter and guide wire exchanges, thereby reducingreducing risk associated with the procedure. Outlined below are methodsutilizing the present technology.

FIG. 12 is a flowchart diagram 1200 of a method for employing thedisclosed catheter system 101 shown in FIGS. 1-11. At box 1202, thecatheter system 101 is advanced with a pre-shaped tip, such as anAmplatzer 1 or AL1, through a puncture site into the vasculature, suchas the femoral artery, of a patient and to a target site of interest inthe body, such as the heart. The step at the box 1202, where the outertubular member 103 fully covers the inner tubular member 203, is shownin FIG. 10a discussed previously. Once the device is brought close tothe aortic valve through the arterial vasculature, at box 1204 thesurgeon's left hand (usually index finger and thumb) is used tostabilize the device by holding the control handle mechanism. Inaddition, the left hand can gently rotate the catheter clockwise orcounterclockwise in order to provide different angles for the distal end107 of the device to cross the stenotic aortic valve. Using the righthand, a straight tipped guide wire 1002, inserted through the Amplatzerlumen, is gently advanced and retracted until it is across the aorticvalve. FIG. 10b shows the actions of the box 1204.

Once the guide wire is across the aortic valve, at box 1206 the cathetersystem 101 is gently advanced into the left ventricle, the straighttipped guide wire 1002 is removed, and the proximal port 111 on thehandle 105 is flushed with sterile saline solution. An external pressuretransducer is then attached to the port 111 to make a pressuremeasurement. FIG. 10c shows the actions of the box 1206. At box 1208,holding the control handle 105 with the right hand, the left hand ismoved to the handle sliding control ring 109. The right hand is in afixed position (usually the entire right hand), and the left hand (indexfinger and thumb) pulls the control ring 109 proximally towards theright hand. Once the handle sliding control ring is fully moved towardsthe right hand, then the outer tubular member 103, for example the AL1shaped catheter, is pulled back and exposes the inner tubular member203, which can be shaped like a pigtail catheter. FIG. 10d shows theouter tubular member 103 partially retracted, and FIG. 10e shows theouter tubular member 103 fully retracted by the movement of the controlring 105 performed at the box 1208.

In this configuration, simultaneous pressure measurements can be made byattaching a second pressure transducer to the side port, which is doneafter appropriate flushing. For example, differential pressure readingsbetween the left ventricle and aorta can be made by two externaltransducers, as described above, attached to each of the two ports onthe present technology which interrogate each of the two lumens withinthe device, respectively. Each of the pressure transducers isinterrogating separate places in the body, for example, in this case theleft ventricle and the aorta. At box 1210, shown in FIG. 10e , thecatheter system 101 is in position, with the inner tubular member 203exposed and in position in the left ventricle, and pressure monitorsoperational. At this point, catheter placement has been completed andthe patient procedure (such as a TAVR or a PCI) may be performed.

Using an alternative embodiment, shown in the handle 605 of FIGS. 6 and8, once in the left ventricle, a control ring mechanism is rotated tounlock the inner tubular member 203 and outer tubular member 103 from afixed relative position. The operator retracts the ring along a definedlongitudinal length moving the ring from one extreme position to theopposite extreme position by moving the control ring mechanism. A hardphysical stop prevents movement beyond the defined extreme positions.These two extreme positions of the control ring mechanism correlate withconversion of the catheter tip configuration from one preset shaped to asecond preset shape, by retracting the outer tubular member 103 andexposing the inner tubular member 203 distal end. In the handleembodiment of FIG. 7, a push button is used to lock/unlock the controlhandle configuration.

In the methods discussed above according to this aspect of the presenttechnology, the user desirably positions the device in an improvedfashion within the left ventricle. The ability to use an initial tipconfiguration (of the outer tubular member 103) for advancement of thecatheter system into the ventricle, and a second tip configuration (ofthe inner tubular member 203) during performance of the procedure oncein place, provides protection against injury to the arteries or theheart wall. The method desirably further includes the step of completingthis shape change without the operator having to look directly at thehandle mechanism. Methods according to this aspect of the presenttechnology afford advantages similar to those discussed above inconnection with the apparatus.

In addition, this catheter can then be used for optimized and improvedplacement of the stiff wire for balloon valvuloplasty and transcatheteraortic valve replacement procedures. A stiff guide wire needed toappropriately stabilize and position the valvuloplasty balloon cathetercan be inserted into presently disclosed inner tubular member 203 andpositioned as desired. The operator would then remove the cathetersystem 101 while maintaining position of the stiff guide wire. Once thecatheter system 101 is fully removed from the guide wire, avalvuloplasty balloon or transcatheter aortic valve can be inserted overthe guide wire into position within the anatomy.

It is understood that the present technology with its quick catheter tipshape change capability can be applied to other applications thatbenefit from the need to reduce device exchanges or procedure time. Forexample, in radial PCI procedures, there is a desire to minimize deviceexchanges in delicate arteries in the arm. Radial procedures offerpatient benefits over traditional femoral artery approaches, reducedrecovery time, and fewer access site bleeding complications. Publishedclinical literature has shown mortality benefits using the radial accessapproach over the more traditional femoral artery approach.Consequently, the use of radial access PCI procedures have supplantedfemoral artery PCI in many labs throughout the world. In addition, manyother applications for the disclosed device are envisioned—includingapplications in the fields of neurology, urology, and peripheralvascular procedures.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms, and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail. Equivalent changes, modifications and variations ofsome embodiments, materials, compositions and methods can be made withinthe scope of the present technology, with substantially similar results.

What is claimed is:
 1. A method of using a concentric two-tube catheterdevice including an inner tubular member and an outer tubular member,the method comprising: slidably disposing one of the inner tubularmember and the outer tubular member relative to the other one of theinner tubular member and the outer tubular member by slidably disposinga control ring upon a handle body of the catheter device to expose adistal end of the inner tubular member from a distal end of the outertubular member, the distal end of the outer tubular member providing afirst shape, the distal end of the inner tubular member providing asecond shape upon exposure thereof, wherein the first shape and thesecond shape are different, wherein a side port is directly attached tothe control ring and is configured to be slidably disposed in unisonwith the control ring relative to the handle body, wherein the side portis in fluid communication with an annular space between the outertubular member and the inner tubular member.
 2. The method of claim 1,wherein the first shape has less curvature than the second shape.
 3. Themethod of claim 1, wherein the first shape has a shorter curved lengththan the second shape.
 4. The method of claim 1, wherein the first shapeincludes one of an Amplatz shape and a Judkins shape.
 5. The method ofclaim 1, wherein the second shape includes a pigtail shape.
 6. Themethod of claim 1, wherein the second shape includes the distal end ofthe inner tubular member curving at least about 270 degrees from aremainder of the inner tubular member.
 7. The method of claim 1, whereinthe first shape includes a hook shape and the second shape includes apigtail shape.
 8. The method of claim 1, wherein the outer tubularmember has a bending stiffness greater than a bending stiffness of theinner tubular member resulting in the second shape of the distal end ofthe inner tubular member conforming to the first shape of the distal endof the outer tubular member when the distal end of the inner tubularmember is covered by the distal end of the outer tubular member.
 9. Themethod of claim 1, wherein the inner tubular member is slidably disposedto extend from the outer tubular member to expose the distal end of theinner tubular member from the distal end of the outer tubular member.10. The method of claim 1, wherein the outer tubular member is slidablydisposed to retract from the outer tubular member to expose the distalend of the inner tubular member from the distal end of the outer tubularmember.
 11. The method of claim 1, wherein slidably disposing one of theinner tubular member and the outer tubular member relative to the otherone of the inner tubular member and the outer tubular member to exposethe distal end of the inner tubular member from the distal end of theouter tubular member includes slidably disposing the control ring uponthe handle body of the catheter device in a proximal to distal directionon the handle body to extend the inner tubular member relative to theouter tubular member and expose the distal end of the inner tubularmember.
 12. The method of claim 1, wherein slidably disposing one of theinner tubular member and the outer tubular member relative to the otherone of the inner tubular member and the outer tubular member to exposethe distal end of the inner tubular member from the distal end of theouter tubular member includes slidably disposing the control ring uponthe handle body of the catheter device in a distal to proximal directionon the handle body to retract the outer tubular member relative to theinner tubular member and expose the distal end of the inner tubularmember.
 13. The method of claim 1, further comprising locking the innertubular member relative to the outer tubular member.
 14. The method ofclaim 1, wherein prior to slidably disposing one of the inner tubularmember and the outer tubular member relative to the other one of theinner tubular member and the outer tubular member to expose a distal endof the inner tubular member from a distal end of the outer tubularmember, the method includes extending a guide wire through the distalend of the inner tubular member.
 15. The method of claim 1, furthercomprising a member selected from a group consisting of: monitoring apressure at the distal end of the inner tubular member; monitoring apressure at the distal end of the outer tubular member; and combinationsthereof.
 16. The method of claim 1, further comprising a member selectedfrom a group consisting of: providing a fluid at the distal end of theinner tubular member; withdrawing a fluid at the distal end of the innertubular member; providing a fluid at the distal end of the outer tubularmember; withdrawing a fluid at the distal end of the outer tubularmember; and combinations thereof.
 17. The method of claim 1, furthercomprising a member selected from a group consisting of: inflating aballoon at the distal end of the inner tubular member; inflating aballoon at the distal end of the outer tubular member; and combinationsthereof.
 18. The method of claim 1, wherein after slidably disposing oneof the inner tubular member and the outer tubular member relative to theother one of the inner tubular member and the outer tubular member toexpose a distal end of the inner tubular member from a distal end of theouter tubular member, the method further comprises a member of a groupconsisting of: delivering and inflating a balloon using the catheterdevice; delivering a stent using the catheter device; and delivering aprosthetic valve using the catheter device.
 19. A method of treating aheart of a patient using a concentric two-tube catheter device includingan inner tubular member and an outer tubular member, the methodcomprising: advancing the catheter device through an artery to the heartof the patient; extending a guide wire through a distal end of the innertubular member across an aortic valve of the heart of the patient;advancing the catheter device into a ventricle of the heart of the heartof the patient; and retracting the outer tubular member relative to theinner tubular member to expose a distal end of the inner tubular memberfrom a distal end of the outer tubular member, the distal end of theouter tubular member providing a first shape, the distal end of theinner tubular member providing a second shape upon exposure thereof,wherein the first shape and the second shape are different, wherein theretracting of the outer tubular member relative to the inner tubularmember includes slidably disposing a control ring upon a handle body ofthe catheter device, wherein a side port is directly attached to thecontrol ring and is configured to be slidably disposed in unison withthe control ring relative to the handle body, wherein the side port isin fluid communication with an annular space between the outer tubularmember and the inner tubular member.
 20. The method of claim 19, furthercomprising a member selected from a group consisting of: monitoring apressure at the distal end of the inner tubular member; monitoring apressure at the distal end of the outer tubular member; providing afluid at the distal end of the inner tubular member; withdrawing a fluidat the distal end of the inner tubular member; providing a fluid at thedistal end of the outer tubular member; withdrawing a fluid at thedistal end of the outer tubular member; inflating a balloon at thedistal end of the inner tubular member; inflating a balloon at thedistal end of the outer tubular member; delivering and inflating aballoon using the catheter device; delivering a stent using the catheterdevice; and delivering a prosthetic valve using the catheter device.